BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: CLAVICLE HOOK PLATE/SCREWS

    MDR report key: 20835457 · Received December 3, 2024

    Report

    Report Number
    8030965-2024-14545
    Event Type
    Injury
    Date Received
    December 3, 2024
    Date of Event
    June 7, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H11: ADDITIONAL NARRATIVE: B3: EXACT DATE OF EVENT IS UNKNOWN; JUNE 07, 2024 IS THE DATE THE LITERATURE ARTICLE WAS PUBLISHED. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. INVESTIGATION SUMMARY: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: TAKATORI N, UCHIYAMA Y, SHIMPUKU E, IMAI T, WATANABE M. COMPARATIVE CLINICAL OUTCOMES AND RADIOLOGICAL IMAGES OF CLAVICLE HOOK PLATE VERSUS SCORPION PLATE® FOR UNSTABLE DISTAL CLAVICLE FRACTURES. J ORTHOP SCI. 2024 JUN 18:S0949-2658(24)00103-9. DOI: 10.1016/J.JOS.2024.06.003. EPUB AHEAD OF PRINT. PMID: 38897850. OBJECTIVE/METHODS/STUDY DATA: THIS RETROSPECTIVE STUDY AIMED TO COMPARE THE CLAVICLE HOOK PLATE AND SCORPION PLATE® IN TERMS OF CLINICAL OUTCOMES AND RADIOLOGICAL FINDINGS FOR UNSTABLE DISTAL CLAVICLE FRACTURES. A TOTAL OF 235 PATIENTS WERE DIAGNOSED WITH DISTAL CLAVICLE FRACTURE BETWEEN 2006 AND 2020 IN OUR HOSPITAL. OF THESE, 111 PATIENTS SHOWED UNSTABLE FRACTURE TYPES (DYSFUNCTION OF THE CORACOCLAVICULAR LIGAMENT; CRAIG CLASSIFICATION TYPE IIB OR TYPE V) [12] AND WE EVALUATED 57 PATIENTS (57 SHOULDERS: 47 MEN; 10 WOMEN) WHO DID NOT UNDERGO ADDITIONAL AUGMENTATION (SUCH AS SUTURE ANCHOR, K-WIRE, OR LIGAMENT RECONSTRUCTION AND COULD BE FOLLOWED-UP FOR >1 YEAR (FIG. 1). THE MEAN DURATION OF FOLLOW-UP WAS 28.1 ± 37.1 MONTHS (RANGE, 12E178 MONTHS) AND MEAN AGE AT THE TIME OF OPERATION WAS 46.4 ± 16.6 YEARS (RANGE, 16E86 YEARS). THE CAUSES OF INJURY WERE A FALL FROM STANDING HEIGHT IN 28 PATIENTS AND TRAFFIC ACCIDENTS IN 29 PATIENTS. CRAIG CLASSIFICATION WAS TYPE IIB IN 50 PATIENTS AND TYPE V IN 7 PATIENTS. IN GROUP H, A SKIN INCISION OF APPROXIMATELY 10 CM IN LENGTH WAS MADE FROM ABOVE THE ACROMIOCLAVICULAR JOINT ALONG THE LONG AXIS OF THE CLAVICLE TO REACH THE FRACTURE REGION. A 2.0-MM KIRSCHNER WIRE WAS USED FOR PROVISIONAL REDUCTION AND THE IDENTIFICATION OF THE POSTERIOR MARGIN OF THE ACROMIOCLAVICULAR JOINT. A HOOK WAS INSERTED UNDER THE ACROMION FROM THE POSTERIOR SIDE OF THE ACROMIOCLAVICULAR JOINT AND PLATE WAS FIXED BY SCREWS. THE IMPLANT USED WAS THE LCP CLAVICLE HOOK PLATE® (DEPUY SYNTHES, WEST CHESTER, PA, USA) FROM 2006 TO 2016, AND THE VARIAX LATERAL HOOK PLATE® (STRYKER GMBH, SELZACH, SWITZERLAND) FROM 2017 TO 2020. IN GROUP S, A SKIN INCISION OF APPROXIMATELY 10 CM WAS MADE FROM ABOVE THE CLAVICLE ALONG THE LONG AXIS OF THE CLAVICLE TO REACH THE FRACTURE REGION. DISTAL FRAGMENT WAS TEMPORARILY FIXED WITH 2.0-MM KIRSCHNER WIRE AFTER REDUCING THE FRACTURE. WE CHECKED THE DISTAL CLAVICLE EDGE USING A 23-G NEEDLE AND POSITIONED THE PLATE ON THE SUPERIOR SIDE OF THE CLAVICLE. THREE PROXIMAL CORTICAL SCREWS AND TWO DISTAL CORTICAL SCREWS WERE INSERTED. THE PLATE ARMS WERE THEN BENT WITH A SPECIAL INSTRUMENT TO PRESSURE-FIX THE DISTAL FRAGMENT. THE IMPLANT USED WAS THE SCORPION PLATE® (AIMEDIC, TOKYO, JAPAN) FROM 2007 TO 2014, AND THE SCORPION NEO PLATE (AIMEDIC) FROM 2015 TO 2020. OTHER DEVICES THAT WERE USED ON THE PATIENT AT THE TIME OF THE EVENT: VARIAX LATERAL HOOK PLATE® DEPUY SYNTHES DEVICE(S) THAT WERE USED IN THIS STUDY: LCP CLAVICLE HOOK PLATE® THE LITERATURE ARTICLE DOES NOT PROVIDE SUFFICIENT INFORMATION TO ASSOCIATED SPECIFIC ADVERSE EVENTS WITH SPECIFIC DEVICE MANUFACTURERS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS CANNOT BE ASSOCIATED WITH A SPECIFIC DEVICE MANUFACTURER DUE TO INSUFFICIENT INFORMATION (QTY 3): 2 PATIENTS HAD HOOK DISLOCATION AND ACROMION FRACTURE; NO INTERVENTION WAS NOTED. 1 PATIENT HAD CLAVICLE FRACTURE OF THE PROXIMAL SIDE OF THE HOOK PLATE; NO INTERVENTION WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2291532 UNK - CONSTRUCTS: CLAVICLE HOOK PLATE/SCREWS PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention